Titles
- Antibiotic prophylaxis in surgery: a national clinical guideline1
- Antimicrobial susceptibility test (AST) system devices: updating breakpoints in device labeling : guidance for industry and Food and Drug Administration staff1
- Application of human factors engineering principles for combination products: questions and answers : guidance for industry and FDA staff1
- Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff1
- Assessing the credibility of computational modeling and simulation in medical device submissions: guidance for industry and Food and Drug Administration staff1
- Assessing the effects of food on drugs in INDs and NDAs: clinical pharmacology considerations1
- Assessing user fees under the Prescription Drug User Fee Amendments of 20171
- Assessing user fees under the biosimilar user fee amendments of 20171
- BCG-unresponsive nonmuscle invasive bladder cancer: developing drugs and biologics for treatment1
- Benefit-risk assessment for new drug and biological products: guidance for industry1
- Best practices for communication between IND sponsors and FDA during drug development: guidance for industry and review staff : good review practice1
- Best practices for convening a GRAS panel: guidance for industry1
- Bioanalytical method validation1
- Brain injury rehabilitation in adults: a national clinical guideline1
- Breakthrough Devices Program: guidance for industry and Food and Drug Administration staff1
- British guideline on the management of asthma: a national clinical guideline1
- CDER’s program for the recognition of voluntary consensus standards related to pharmaceutical quality: guidance for industry1
- Cancer clinical trial eligibility criteria: available therapy in non-curative settings1
- Cannabis and cannabis-derived compounds: quality considerations for clinical research : guidance for industry1
- Care of deteriorating patients: consensus recommendations1